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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K182861
Device Name Shiley Neonatal/Pediatric Tracheostomy Tube
6135 Gunbarrel Ave
Boulder,  CO  80301
Applicant Contact Yaara Basevitch
6135 Gunbarrel Ave
Boulder,  CO  80301
Correspondent Contact Yaara Basevitch
Regulation Number868.5800
Classification Product Code
Date Received10/11/2018
Decision Date 03/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No